EMA approves Perjeta ( Roche) for treatment of metastatic Breast Cancer
Roche has announced that the European Medicines Agency (EMA) has approved Perjeta(pertuzumab) for patients with previously untreated HER2-positive metastatic Breast Cancer (mBC). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable Breast Cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
The European approval comes after the Phase III CLEOPATRA trial showed that the combination of Perjeta, Herceptin and chemotherapy provided patients with a median of 6.1 months longer without their disease worsening or death (progression-free survival, PFS) and provided a 34 percent reduction in the risk of death (overall survival) compared to Herceptin and chemotherapy alone.
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